Diagnostic and Prognostic Value of Angiography-derived IMR

NCT04825028 | Unknown DMC

• 1 other identifier: ZS-20210328
• Study Type: observational
• Target: 271
• Locations: 1 country
• Sites: 1

Brief Summary

The importance of the microvasculature in determining clinical outcomes has been highlighted in patients with coronary artery disease (CAD). For patients with stable CAD, despite the success of percutaneous coronary intervention (PCI) in relieving a stenosis in the epicardial coronary artery, microvascular dysfunction may preclude sufficient coronary flow and myocardial perfusion, possibly leading to worse clinical outcome. With the technical development of computational fluid dynamics, angiographic derivation of index of Index of Microcirculatory Resistance (IMR) without pressure wire, hyperemic agents, or theromdilution method is available as a potential alternative for pressure wire-derived IMR. In this regard, the current study will evaluate diagnostic implication of angiography-derived IMR and its prognostic implication after PCI in patients with stable CAD.

Conditions

Coronary Microvascular Dysfunction; Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy

  Correlation between angiography-derived IMR and HMR

  at the index procedure

• Major adverse cardiac events

  Major adverse cardiac events (MACE), including cardiac death and readmission due to heart failure.

  at 28 months from index procedure

Secondary Outcomes (7)

• A composite of cardiac death, readmission due to heart failure and angina

  at 28 months from index procedure

• A composite of cardiac death, readmission due to heart failure, spontaneous MI, target vessel revascularization and angina

  at 28 months from index procedure

• Cardiac death

  at 28 months from index procedure

• Readmission due to heart failure

  at 28 months from index procedure

• Spontaneous MI

  at 28 months from index procedure

Study Arms (3)

Internal Diagnostic Accuracy Cohort

Consecutive patients with available CZT-SPECT within 3 months of measuring FFR in the left anterior descending coronary artery. In these patients, correlation between angiography-derived IMR and hyperemic microvascular resistance will be assessed.

Device: Angiography-drived Index of Microcirculatory Resistance

External Diagnostic Accuracy Cohort

Patients are subgroup of previously published study (J Nucl Cardiol. 2020 Sep 30. doi: 10.1007/s12350-020-02252-8.), INOCA patients and normal controls confirmed by CZT-SPECT and angiography will be included for the assessment of angiography-derived IMR in diagnosing microvascular dysfunction.

Device: Angiography-drived Index of Microcirculatory Resistance

Prognosis Cohort

Prognosis cohort, in which angiography-derived IMR will be measured in the target vessel after successful revascularization. Those patients have follow-up data after 2 years from index procedure.

Device: Angiography-drived Index of Microcirculatory Resistance

Interventions

Angiography-drived Index of Microcirculatory Resistance DEVICE

From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation. Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}). Hyperemic Pa will be estimated from resting Pa according to prespecified equation.

Also known as: Angio-IMR, CaIMR

External Diagnostic Accuracy Cohort; Internal Diagnostic Accuracy Cohort; Prognosis Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnostic Accuracy Cohort, 53 stable CAD patients who underwent CZT-SPECT MBF and invasive pressure measurements in LAD within 7 days. Diagnostic Accuracy Cohort, 35 INOCA patients confirmed by CZT-SPECT and coronary angiography and 45 normal controls Prognosis Cohort 138 stable patients received PCI with available angiograms and who were suitable for angiographic FFR and IMR measurement and have 28 months follow-up data.

You may qualify if:

• CAD patients with available CZT-SPECT within 3 months of measuring FFR in the left anterior descending coronary artery (Cohort 1)
• INOCA patients and normal controls confirmed by CZT-SPECT and angiography (Cohort 2)
• Stable CAD patients received PCI (Cohort 3)
• analyzable angiograms at the index procedure

You may not qualify if:

• Previous coronary artery bypass grafting
• Chronic total occlusion patients
• limited image quality of coronary angiography
• Insufficient angiographic project for TIMI frame count
• Severe tortuosity of target vessel
• No optimal projection for reconstruction

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, 200091, China

Location

Related Publications (3)

• De Maria GL, Scarsini R, Shanmuganathan M, Kotronias RA, Terentes-Printzios D, Borlotti A, Langrish JP, Lucking AJ, Choudhury RP, Kharbanda R, Ferreira VM; Oxford Acute Myocardial Infarction (OXAMI) Study Investigators; Channon KM, Garcia-Garcia HM, Banning AP. Angiography-derived index of microcirculatory resistance as a novel, pressure-wire-free tool to assess coronary microcirculation in ST elevation myocardial infarction. Int J Cardiovasc Imaging. 2020 Aug;36(8):1395-1406. doi: 10.1007/s10554-020-01831-7. Epub 2020 May 14.

  PMID: 32409977 BACKGROUND

• Ai H, Feng Y, Gong Y, Zheng B, Jin Q, Zhang HP, Sun F, Li J, Chen Y, Huo Y, Huo Y. Coronary Angiography-Derived Index of Microvascular Resistance. Front Physiol. 2020 Dec 16;11:605356. doi: 10.3389/fphys.2020.605356. eCollection 2020.

  PMID: 33391020 RESULT

• Dai N, Che W, Liu L, Zhang W, Yin G, Xu B, Xu Y, Duan S, Yu H, Li C, Yao K, Huang D, Ge J. Diagnostic Value of Angiography-Derived IMR for Coronary Microcirculation and Its Prognostic Implication After PCI. Front Cardiovasc Med. 2021 Oct 15;8:735743. doi: 10.3389/fcvm.2021.735743. eCollection 2021.

  PMID: 34722667 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Junbo Ge, Professor

  Fudan University

  STUDY CHAIR

Central Study Contacts

Neng Dai, MD

CONTACT

+8613701997266; niceday1987@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)